The #1 FSMA Element Most Produce Importers Fail to Get Right

By Dan Simonsen, EAS Consulting Group Independent Consultant

If you import fresh produce, there’s a good chance your FSVP is missing the same thing almost every produce importer misses. It’s the top 483 observation FDA writes up for covered produce, and it isn’t about recordkeeping. It’s the evaluation required under 21 CFR § 1.505, specifically the evaluation tied to the Produce Safety Rule (PSR).

Why the Produce Safety Rule Matters

Produce is where FSMA has done its heaviest lifting. Before the PSR existed, CDC attribution data covering 1998 to 2008 found that produce accounted for nearly half of all foodborne illnesses during that period. FDA’s own review of outbreak data from 1996 to 2010 documented 131 produce-linked outbreaks, more than 14,000 illnesses, and 34 deaths, the numbers that built the case for Part 112 in the first place. Sprouts alone accounted for 43 outbreaks and over 2,400 illnesses between 1996 and 2014, which is why the rule singles them out with their own subpart. When FDA proposed the rule, its economic analysis projected it would prevent an estimated 1.75 million foodborne illnesses a year. The PSR took effect in January 2016 and is a critical part of a produce importer’s FSVP. It remains the only FSMA rule written specifically for what happens on the farm, and it reshaped how produce is grown, harvested, and packed for the U.S. market more than any single regulation before it.

FDA’s Most Common Observation for Produce Importers

Part 1.502(a) explicitly states that covered produce importers must provide adequate assurances that their foreign supplier produces food in compliance with processes and procedures that offer the same level of public health protection as the PSR. Sections 1.505 (supplier evaluation) and 1.506 (supplier verification) call back to this requirement. Despite its importance, adequate documentation is not maintained for either section. What often occurs instead is an unsigned, half-complete checkbox questionnaire from the grower, attempting to be passed as a supplier evaluation. Or third-party audit certificates of a consolidator’s management structure from three years ago as supplier verification. True evaluation and verification are often not conducted. 

A Practical Way to Strengthen Your Supplier Evaluation

There’s one practical correction that fixes this: work backwards and use what FDA has already told you. Under the  FDA’s Third-Party Food Safety Standards Alignment Pilot Program, FDA reviewed private audit standards and published findings on where those standards align with the technical requirements of Part 112. First, understand the primary audit schemes that achieved this specific alignment for produce operations include: GLOBALG.A.P. IFA (with the FSMA PSR Add-on) or USDA Harmonized GAP / Harmonized GAP Plus+. Second, if your foreign supplier already holds a current audit report under one of these standards, don’t just file the certificate. Cite the alignment finding directly in your written evaluation and explain how the audited elements map to the hazards identified. That gives you a documented, defensible basis for concluding the supplier’s practices provide the same level of public health protection required under the PSR, which is precisely what § 1.502 is asking you to show.

FDA isn’t looking for a perfect evaluation or verification. It’s looking for evidence that they happened: a review, made before the food is imported, with the reasoning behind it written down. That’s a lower bar than most importers think, and a higher one than most FSVPs actually clear. If you haven’t tested yours against it, the FDA eventually will.